LesionQuant

GUDID 00863725000317

CORTECHS LABS INC

MRI system application software

• Primary Device ID: 00863725000317
• NIH Device Record Key: c87ee325-ca22-4738-9d76-e921b3224947
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LesionQuant
• Version Model Number: LQ
• Company DUNS: 086086498
• Company Name: CORTECHS LABS INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00863725000317 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061855

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-05
• Device Publish Date: 2016-09-24

Devices Manufactured by CORTECHS LABS INC

• 00863725000300 - NeuroQuant: 2020-02-05
• 00863725000317 - LesionQuant: 2020-02-05
• 00863725000317 - LesionQuant: 2020-02-05